Supplier Quality Engineer

Responsibilities Support supplier quality management activities in accordance with applicable regulatory requirements and industry standards. Conduct supplier qualification activities, including supplier assessments, questionnaires, risk evaluations, and audits as appropriate. Investigate supplier quality issues, issue supplier corrective action requests, and drive timely resolution. Develop, review, and maintain supplier quality agreements. Evaluate supplier and material changes, coordinate cross-functional reviews, and ensure completion of change control activities. Participate in internal quality audits and monitor implementation of corrective and preventive actions. Support regulatory inspections and customer audits by preparing documentation and responding to quality-related requests. Maintain quality documentation, including electronic filing and document control. Track supplier quality metrics and identify opportunities for continuous improvement. Execute assigned quality projects while meeting established timelines. Promote compliance with quality systems, safety policies, and company procedures. Qualifications Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related scientific discipline, or equivalent industry experience. 3+ years of quality experience within a regulated pharmaceutical, biotechnology, medical device, or life sciences manufacturing environment. Strong understanding of Quality Management Systems (QMS) and applicable regulatory requirements, including cGMP. Experience with supplier quality processes, including supplier qualification, corrective actions, change control, audits, complaints, deviations, and document management. Familiarity with risk assessment methodologies and statistical analysis tools. Proficiency with Microsoft Office applications and quality documentation systems. Excellent analytical, problem-solving, and organizational skills. Strong written and verbal communication skills with the ability to collaborate across multiple functional areas. Ability to manage multiple priorities in a fast-paced, regulated environment while exercising sound independent judgment. Preferred Experience Experience supporting regulated manufacturing operations within pharmaceutical, biotechnology, medical device, or related industries. Familiarity with global regulatory standards and quality frameworks, including FDA, ISO, and international quality regulations. Experience participating in supplier audits, regulatory inspections, and continuous improvement initiatives. #J-18808-Ljbffr